Efavirenz (Sustiva®): Oral Liquid Expanded Access Program for Children and Adolescents Ages 3-16
May 5, 2000
Efavirenz is an approved antiretroviral currently available in the U.S. and other countries in capsule form -- and recommended for pediatric use in the latest Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection (January 2000). A liquid formulation for persons who have difficulty using the capsules is currently being tested.
A new expanded-access program, announced April 27, 2000, will make the oral drug available through an FDA-approved study protocol, for children and adolescents from ages 3 to 16. According to DuPont Pharmaceuticals, the company will make the new formulation available in all areas where it has marketing rights to the drug.
An application for approval of the oral formulation has been filed in Europe, and applications will be submitted in the U.S. and Canada later this year.
In the U.S., physicians can call 1-877-372-7097 to receive information and enrollment materials for the Sustiva® Oral Liquid Expanded Access Program.
Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.
This article was provided by AIDS Treatment News. It is a part of the publication AIDS Treatment News.